Three dimensional devices and methods for prolapse alleviation

ABSTRACT

A device sized and shaped for alleviating pelvic organ prolapse when inserted into a vagina, comprising: a treatment rendering portion configured to be adjustable between a first, collapsed state and a second, expanded state, where the second expanded state extends substantially in three dimensions.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/767,401, filed on Apr. 11, 2018, which is a National Phase of PCTPatent Application No. PCT/IL2016/051113 having International FilingDate of Oct. 13, 2016, which claims the benefit of priority under 35 USC§ 119(e) of U.S. Provisional Patent Application No. 62/240,572 filed onOct. 13, 2015. The contents of the above applications are allincorporated by reference as if fully set forth herein in theirentirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to thehealth care industry and, more particularly, but not exclusively, todevices and methods for treating feminine pelvic organ prolapse.

Pelvic organ prolapse occurs when the network of muscles, ligaments, andtissues that hold the pelvic organs in place is weakened and one or morepelvic organs descend into the vaginal cavity. Pelvic organ prolapseoccurs as a result of normal aging, childbirth, pelvic surgery ortrauma, and may include one or more of the following conditions:

i) Cystocele, the leading form of pelvic organ prolapse, wherein thebladder drops into the vagina and may be associated with urinationproblems;

ii) Rectocele, wherein the rectum herniates into the vagina and mayresult in difficulty and/or pain with defecation;

iii) Enterocele, wherein the small intestine prolapses into the vagina;

iv) Uterine prolapse wherein the uterus drops downward into the vaginaand is often associated with other organ prolapse; and

v) Vaginal vault prolapse, wherein the top portion of the vagina, theapex, loses its natural shape and drops down into the lower vaginalcanal, and may occur in women who had a hysterectomy.

To avoid surgical procedures to treat pelvic organ prolapse, a number ofnon-surgical vaginal devices, pessaries, have been designed to beinserted into the vagina by a surgeon, medical assistant or user.

Background art includes the following patents, the contents of all ofwhich are incorporated by reference as if fully set forth herein:

WO 2009/130702: Pessaries for Prolapse Alleviation;

U.S. Pat. No. 8,651,109: Pessaries for Prolapse Alleviation;

WO 9601084: Inflatable Vaginal Pessary;

GB 235218: Inflatable Pessary;

FR 2843700: Rehabilitation Device for Urinary and Faecal Continence;

WO 03047476: Vaginal Pessary;

GB 1115727: Apparatus Controlling Incontinence in the Female;

U.S. Pat. No. 5,224,494: Vaginal Pessary;

U.S. Pat. No. 6,158,435: Pessary;

US 2003149334: Vaginal Pessary;

JP 6133996: Pessary for Treating Prolapse of Uterus;

U.S. Pat. No. 4,823,814: Pessary;

U.S. Pat. No. 5,771,899: Pessary;

U.S. Pat. No. 5,894,842: Pessary for Treating Vaginal Prolapse;

U.S. Pat. No. 6,158,435: Pessary;

U.S. Pat. No. 6,216,698: Flexible Pessary;

U.S. Pat. No. 6,503,190: Vaginal Pessary;

U.S. Pat. No. 6,808,485: Compressible Resilient Vaginal IncontinenceInsert; and

U.S. Pat. No. 7,036,511: Vaginal Pessary.

SUMMARY OF THE INVENTION

There is provided, in an accordance with an exemplary embodiment of theinvention, a device sized and shaped for alleviating pelvic organprolapse when inserted into a vagina, comprising: a treatment renderingportion configured to be adjustable between a first, collapsed state anda second, expanded state, where the second expanded state extendssubstantially in three dimensions.

In an embodiment of the invention, the treatment rendering portioncomprises a plurality of bendable arcs.

In an embodiment of the invention, the device further comprises anexternal tube and an internal tube coaxial with and slidable within theexternal tube.

In an embodiment of the invention, distal ends of the bendable arcs areconnected to the external tube and proximal ends of the bendable arcsare connected to the internal tube.

In an embodiment of the invention, proximal ends of the bendable arcsare integral with the internal tube and distal ends of the bendable arcsare connected to the external tube.

In an embodiment of the invention, the internal tube and the externaltube releasably interlock to prevent sliding when in the expanded state.

In an embodiment of the invention, the external tube is configured witha slot within which at least one locking pin of the internal tube isreceived to interlock the external and internal tubes.

In an embodiment of the invention, the treatment rendering portion is anouter bar tube with a distal end connected to an upper tube and with aproximal end connected to a lower tube, where the lower tube is coaxialand slidable within the upper tube and where the upper and lower tubesare coaxial and internal to the outer bar tube.

In an embodiment of the invention, the upper tube and the lower tubereleasably interlock to prevent sliding when in the expanded state.

In an embodiment of the invention, the upper tube is configured with aslot within which at least one locking pin of the lower tube is receivedto interlock the upper and lower tubes.

In an embodiment of the invention, the treatment rendering portioncomprises a spiral cut tube, with a distal end connected to an uppertube and with a proximal end connected to a lower tube, where the lowertube is coaxial and slidable within the upper tube and where the upperand lower tubes are coaxial and internal to the outer bar tube.

In an embodiment of the invention, the upper tube and the lower tubereleasably interlock to prevent sliding when in the expanded state.

In an embodiment of the invention, the upper tube is configured with aslot within which at least one locking pin of the lower tube is receivedto interlock the upper and lower tubes.

In an embodiment of the invention, the treatment rendering portioncomprises at least two component elements, an upper element and a lowerelement, where the elements are positioned concentrically opposing andorthogonal to each other.

In an embodiment of the invention, the upper element is provided with anouter telescoping tube and the lower element is provided with a toothed,sliding post, where the sliding post slides coaxially within thetelescoping tube during device expansion into the expanded state.

In an embodiment of the invention, at least one tooth is provided to adistal end of the sliding post and where the tooth is configured toreversibly lock the device into the expanded state when the at least onetooth moves past a block provided in a slot in the outer telescopingtube.

In an embodiment of the invention, the treatment rendering portion isshaped like a sphere.

In an embodiment of the invention, the treatment rendering portion isshaped like a pear.

In an embodiment of the invention, the treatment rendering portion isshaped like an ovoid.

In an embodiment of the invention, the treatment rendering portion isshaped like a cuboid.

In an embodiment of the invention, the treatment rendering portion isrotationally symmetric.

In an embodiment of the invention, the treatment rendering portion doesnot exhibit uniform flexibility around its circumference in the expandedstate.

In an embodiment of the invention, the treatment rendering portionexhibits a plurality of planes of flexibility.

In an embodiment of the invention, the device is configured to bepermeable to vaginal secretions.

In an embodiment of the invention, at least a portion of the treatmentrendering portion is provided with a covering.

In an embodiment of the invention, the device further comprises alocking mechanism.

In an embodiment of the invention, the locking mechanism comprises atleast one tooth configured to move in a slot, wherein when the slot isprovided with a block at least one locking pin is in the window thedevice is reversibly locked.

In an embodiment of the invention, the locking mechanism comprises atleast one locking pin configured as a counterpart to a window or slot,wherein when the at least one locking pin is in the window the device isreversibly locked.

In an embodiment of the invention, the device further comprises aremoval device for converting the device from the second, expanded stateto the first, collapsed state.

In an embodiment of the invention, the removal device comprises astring.

In an embodiment of the invention, the removal device further comprisesa removal disk attached to the string.

In an embodiment of the invention, the removal device further comprisesa holding bar attached to the string.

In an embodiment of the invention, the treatment rendering portioncomprises three or more plastic arcs connected to two concentrictelescopic elements.

In an embodiment of the invention, the treatment rendering portioncomprises coaxial telescopic elements and a plurality of block elements.

In an embodiment of the invention, the treatment rendering portioncomprises at least two orthogonal ring elements, forming arcs, with aplurality of blocks connected to an internal side of the arcs.

There is further provided in accordance with an exemplary embodiment ofthe invention, a system for alleviating pelvic organ prolapse wheninserted into a vagina, comprising: (a) a device according to claim 1;and, (b) an applicator.

In an embodiment of the invention, the applicator comprises a holder anda puller.

In an embodiment of the invention, a distal end of the puller isconfigured with a prong for releasably holding the device to theapplicator.

In an embodiment of the invention, the puller is configured withsnapping teeth for releasably holding the device to the applicator.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example, and not necessarily to scale,and are for purposes of illustrative discussion of embodiments of theinvention. In this regard, the description taken with the drawings makesapparent to those skilled in the art how embodiments of the inventionmay be practiced.

In the drawings:

FIGS. 1A-1B are perspective views of a collapsed and open, respectively,ball-type prolapse treating device with individual arcs connected to twotubes and attached to an applicator, in accordance with an exemplaryembodiment of the invention;

FIG. 2 is an exploded view of the collapsed ball-type prolapse treatingdevice with individual arcs between two tubes and the applicator of FIG.1A, in accordance with an exemplary embodiment of the invention;

FIG. 3A is a perspective view of the prolapse treating device of FIG. 1Bseparated/deployed from the applicator, in accordance with an exemplaryembodiment of the invention;

FIGS. 3B-3C are cross-sectional views of the device of FIG. 1Bseparated/deployed from the applicator, in accordance with an exemplaryembodiment of the invention;

FIGS. 4A-4B are perspective views of a collapsed and open, respectively,ball-type prolapse treating device with individual arcs integrated withone of two tubes and attached to an applicator, in accordance with anexemplary embodiment of the invention;

FIG. 5 is a perspective view of the lower tube with integrated arcs ofFIGS. 4A-4B, in accordance with an exemplary embodiment of theinvention;

FIG. 6 is an exploded view of the collapsed ball-type prolapse treatingdevice and the applicator of FIG. 4A, in accordance with an exemplaryembodiment of the invention;

FIGS. 7A-7B are perspective closed and open, respectively, views of aball-type prolapse treating device with an outer bar tube attached to anapplicator, in accordance with an exemplary embodiment of the invention;

FIG. 8 is an exploded view of the ball-type prolapse treating device andthe applicator of FIG. 7A, in accordance with an exemplary embodiment ofthe invention;

FIGS. 9A-9B are side views of the ball-type device of FIG. 7B showing aholding bar extended and retracted, respectively, in accordance with anexemplary embodiment of the invention;

FIGS. 10A-10B are perspective closed and open, respectively, views of aball-type prolapse treating device with an outer spiral tube attached toan applicator, in accordance with an exemplary embodiment of theinvention;

FIG. 11 is an exploded view of the ball-type prolapse treating deviceand the applicator of FIG. 10A, in accordance with an exemplaryembodiment of the invention;

FIGS. 12A-12B are side views of the ball-type device of FIG. 10B showinga holding bar extended and retracted, respectively, in accordance withan exemplary embodiment of the invention;

FIGS. 13A-13B are perspective closed and open, respectively, views of aball-type prolapse treating device with opposing u-shaped elementsattached to an applicator, in accordance with an exemplary embodiment ofthe invention;

FIG. 14 is a perspective view of the ball-type prolapse treating deviceof FIG. 13A split apart, in accordance with an exemplary embodiment ofthe invention;

FIG. 15A is a cross-sectional view of the device of FIG. 13A, inaccordance with an exemplary embodiment of the invention;

FIG. 15B is a close-up, cross-sectional view of a locking mechanism ofthe device of FIG. 13A, in accordance with an exemplary embodiment ofthe invention;

FIGS. 16A-16C are perspective views of a prolapse treating device inclosed and opened states made of elastic arcs connected by coaxialtelescopic elements, in accordance with an exemplary embodiment of theinvention;

FIG. 17 is an exploded view of the prolapse treating device of FIG. 16A,in accordance with an exemplary embodiment of the invention;

FIGS. 18A-18B are front views of the device of FIG. 16A, in accordancewith an exemplary embodiment of the invention;

FIG. 19A is a cross-sectional view of the device of FIG. 16A, inaccordance with an exemplary embodiment of the invention;

FIG. 19B is a close-up, cross-sectional view of a locking mechanism ofthe device of FIG. 16A, in accordance with an exemplary embodiment ofthe invention;

FIGS. 20A-20B are perspective closed and open, respectively, views of aprolapse treating device made of coaxial telescopic elements and aplurality of block elements, in accordance with an exemplary embodimentof the invention;

FIG. 21 is an exploded view of the prolapse treating device of FIG. 20A,in accordance with an exemplary embodiment of the invention;

FIG. 22 is a front view of a chain made of a plurality of blockelements, in accordance with an exemplary embodiment of the invention;

FIG. 23A is a cross-sectional view of the device of FIG. 20A, inaccordance with an exemplary embodiment of the invention;

FIG. 23B is a close-up, cross-sectional view of a locking mechanism ofthe device of FIG. 20A, in accordance with an exemplary embodiment ofthe invention;

FIGS. 24A-24B are perspective views of a prolapse treating device inclosed and opened states made of two orthogonal ring elements joined intheir bases (upper and lower) by coaxial telescopic elements, inaccordance with an exemplary embodiment of the invention;

FIG. 25 is an exploded view of the ball-type prolapse treating device ofFIG. 24A, in accordance with an exemplary embodiment of the invention;

FIGS. 26A-26B are front views of one of the ring elements in closed andopened states, in accordance with an exemplary embodiment of theinvention;

FIG. 27A is a cross-sectional view of the device of FIG. 24A, inaccordance with an exemplary embodiment of the invention;

FIG. 27B is a close-up, cross-sectional view of a locking mechanism ofthe device of FIG. 24A, in accordance with an exemplary embodiment ofthe invention;

FIG. 28A is a cross-sectional view of the device of FIG. 24A, in pulledremoval string state, in accordance with an exemplary embodiment of theinvention;

FIG. 28B is a close-up, cross-sectional view of a locking mechanism ofthe device of FIG. 24A, in pulled removal string state, in accordancewith an exemplary embodiment of the invention;

FIG. 29A is a perspective cross-sectional view of device of FIG. 24A andits applicator, in accordance with an exemplary embodiment of theinvention; and

FIGS. 29B-29C are close up views of FIG. 29A.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to thehealth care industry and, more particularly, but not exclusively, todevices and methods for treating feminine pelvic organ prolapse.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings. The invention is capable of otherembodiments or of being practiced or carried out in various ways. Itshould also be understood that in this specification, “distal” or“distally” means in the direction of or on the side of the cervix and“proximal” or “proximally” means in the direction of or on the side ofthe vaginal introitus.

The Devices Generally

In general, devices and methods are described for the treatment offeminine pelvic organ prolapse. It should be understood that features,forms and/or functions overlap among some or many of the embodimentsthat will be described herein and that description in relation to oneembodiment may also apply to others. For brevity and efficiency, many ofthese common features and/or forms and/or functions are described onlyin this “Generally” section but apply to one, some or all embodiments.Specific distinctions between embodiments in features, form and/orfunction are described in additional sections below.

In some embodiments of the invention, the devices described herein aregenerally three dimensional (extend substantially in 3 dimensions)and/or are rotationally symmetric and/or are not rotation sensitive inorder to render treatment. In some embodiments of the invention, thedevice is ball/spherical, pear, box/cube/cuboid, ovoid shaped or thelike. Throughout the specification, where “ball” is used, it could meanany conceivable three dimensional shape appropriate for renderingprolapse treatment, for example any of those described above. Differentexemplary device embodiments are described in detail below.

The device, or at least the ball portion of the device, is constructedof a plurality of arc sections, optionally 3 or more, where in the caseof 3 arcs, each arc defining a dimension of the device, in an embodimentof the invention. In some embodiments of the invention, at least thearcs of the device are constructed of a bio-compatible material ormaterials and, optionally, of a material or materials which do notfacilitate vaginal flora changes. Exemplary materials include highdensity polyurethane (for the plastic/skeletal part) and thermoplasticelastomers or silicone for the covering. In some embodiments of theinvention, the device is configured to be permeable or to allow vaginalsecretions to exit the vagina.

In some embodiments of the invention, the external surface of the deviceis smooth, for example to increase comfort to the user, reducedaccumulated discharge and/or reduce the production of biofilms.

In an embodiment of the invention, at least one arc of the ball portionis at least partially covered by a padding or exterior layer (whichwould then be the external surface of the device, taking the place ofthe at least one arc itself as the external surface). Optionally, thelayer is configured to at least enhance user comfort and/or to reduce orprevent tissue necrosis. Optionally, the layer is configured to permitvaginal secretions to exit the vagina. Optionally, the layer is rigid.

In some embodiments of the invention, a removal string is operativelyconnected to the device to enable a user to displace the device from thevagina and remove it from her body.

In an embodiment of the invention, a locking mechanism is provided tothe device, for example to enable the device to lock into an expandedand/or closed state. Different exemplary locking mechanism embodimentsare described below, for example including snapping elements and/or pinsand/or teeth and/or slots and/or windows. In some embodiments of theinvention, the device is bi-stable. Optionally the bi-stable feature isfacilitated by the locking mechanism. In some embodiments of theinvention, the locking mechanism is activated by an applicator used forinserting the device. In some embodiments of the invention, the lockingmechanism is deactivated by the removal string. In some embodiments ofthe invention, the locking mechanism is activated and/or deactivated bysomething other than mechanical forces, for example using magnetic,electric, pneumatic, and/or hydraulic force.

The devices described herein are configured to accommodate a pluralityof vaginal sizes and/or shapes, in some embodiments of the invention.For example, the devices optionally are provided in a variety of sizesand/or shapes and/or flexibilities.

In some embodiments of the invention, device shape is predefined but notpermanent, that is, once deployed inside the patient the flexibility ofthe device allows some shape matching to the user's individualanatomical features. In some embodiments of the invention, a range ofdevices will exhibit in the expanded state diameters of 40-75 mm (thediameter pertains to the maximal distance between two opposite elementsof the device in contact with the vagina). In some embodiments of theinvention, devices exhibit a collapsed diameter of 35 mm or less.

In some embodiments of the invention, the device does not exhibit auniform flexibility around the circumference of the device. For example,the device is rigid in two dimensions (in a plane) at 0° and 180° (goingaround arcs or arms of the device) but is flexible at all other points.As another example, the device is rigid in two dimensions (defining aplane of flexibility) at 0° and 180°, is less rigid at 90° and 270° andis flexible elsewhere. In some embodiments of the invention, the arcs orarms of the device increase in rigidity towards 0° and 180° and increasein flexibility towards 90° and 270°. In some embodiments of theinvention, the device is configured such that mirror image portions ofarcs or arms of the device (any subsection up to and between 180°) flextowards each other. It should be understood that flexibility can bedemonstrated selectively anywhere around the circumference of the armsor arcs, for example at 45° and/or 135° additionally and/oralternatively to 90° and 270°. In some embodiments of the invention, thedevice exhibits alternating and/or regular rigidity and flexibilityaround the circumference of the device. In some embodiments of theinvention, flexibility of the device corresponds to planes offlexibility, for example in a three dimensional device there could bethree major planes of flexibility. Optionally, the flexibility aroundthe circumference of the device is configured so that the device willexhibit a particular desired shape, for example arcs that are moreflexible at the distal end than at the proximal end might imbue a pearshape to the device when expanded.

It should be understood that these are examples only, and that anycombination of rigidity and flexibility, including no rigidity or noflexibility are permitted, depending on the intended use and/or needs ofthe user.

In some embodiments of the invention, sizes and/or shapes and/orflexibilities are chosen to reduce pressure on vaginal walls and/orprovide better force distribution of the device on vaginal walls and/orto reduce the probability of pressure necrosis, optionally incombination with the padded covering/exterior layer.

In some embodiments of the invention, the device and the applicator,together, comprise a system for inserting and deploying the prolapsealleviating device.

In some embodiments of the invention, the device is offered in aplurality of sizes and/or determination of which specific device is mostappropriate for a certain user is performed by a sizing deviceconfigured for indicating a device size to the user or to an attendingmedical professional. In some embodiments of the invention, the sizingdevice changes diameter and/or state to known device sizes and/or statesin order to determine the proper device that should be used by the user.In some embodiments of the invention, a “fit-kit”, comprised of aplurality of different sized devices (or dummies representing differentdevice sizes), is used by the patient to self-diagnose the proper sizeby trying out the different sizes until the most appropriate one isfound. In some embodiments of the invention, an attending medicalprofessional uses the fit-kit.

In some embodiments of the invention, the device is disposed of afteruse. In some embodiments of the invention, the device is reusable and/orconfigured to be reused (for example, is washable/sterilizable).

Function and Modes of Operation

In some embodiments of the invention, operation of the devices describedherein can be divided into three general phases: i.)insertion/deployment, ii.) use (i.e. wearing the device), and iii.)removal.

With respect to insertion, devices are inserted with a particularpredetermined orientation (or with orientation assistance) or are notsensitive to insertion orientation (e.g. are rotationally symmetrical),depending on the particular embodiment. In some embodiments of theinvention, devices described herein are inserted in a closed, compactedand/or collapsed state for ease of storage and/or insertion.

In some embodiments of the invention, devices are inserted manually,without an applicator. Optionally, the user or a caregiver inserts thedevice manually. In some embodiments of the invention, devices areinserted with an applicator, which optionally also assists withorientation and/or deployment/expansion of the device. In someembodiments of the invention, depth of insertion is a factor to beconsidered.

Optionally, an applicator used for inserting a device is configured, forexample the grip of the applicator is located such that proper insertiondepth is established when the patient inserts the device until thefingers holding the applicator touch the labia. In some embodiments ofthe invention, the applicator is disposed of after device insertionand/or deployment.

In some embodiments of the invention, at least one of the devices(optionally including an applicator) described herein is configured tobe inserted and/or deployed with only one hand. In other cases theapplicator may be held with two hands (fingers 1+3 of both hands, andthe plunger pushed forward with the 2 index fingers, or held with twohands and plunger pushed with one index finger. In some embodiments ofthe invention, at least one device (optionally including an applicator)is configured to be insertable and/or deployable regardless of theuser's position, for example while the user is in a supine, standing orsitting position. In some embodiments of the invention, at least onedevice (optionally including an applicator) is configured to beinsertable and/or deployable minimizing user self-touching. For example,the user does not have to separate the labia in order to insert thedevice and/or does not need to insert fingers into the vagina in orderto position the device.

With respect to usage of the devices described herein, in someembodiments of the invention they are inserted into the user in order totreat pelvic organ prolapse and/or to support the vaginal walls, thatis, to provide support from the vagina against organs sagging down intothe vaginal canal. In some embodiments of the invention, devicesdescribed herein are expanded and/or change state for use. In someembodiments of the invention, the devices described herein treat pelvicorgan prolapse by stretching vaginal walls, optionally laterally,flattening the anterior and posterior vaginal walls and thereby reducinganterior and posterior prolapse. In some embodiments of the invention, aspace occupying characteristic of the devices described herein treatapical prolapse, whereby the vaginal apex (uterine/vault) is not allowedto descend. The devices described herein are removed after insertionperiodically. Optionally, the devices herein are reusable. In someembodiments of the invention, the devices described herein areconfigured to elute pharmaceutical substances into the user.

With respect to removal of the devices described herein, the deviceschange from an expanded and/or deployed state into a closed, compactedand/or collapsed state for ease of removal. Optionally the removalstate/configuration is the same as the storage/insertionstate/configuration. In some embodiments of the invention, removal iseffectuated by pulling on a removal string which is operativelyconnected to the device. Optionally, forces applied to the removalstring are configured to also cause state/configuration change of thedevice from an expanded state to a collapsed state.

Optionally, in cases where vaginal walls are lax, a pull of the stringwill cause extraction of the device still in its deployed state,somewhat deformed due to its flexibility, before the pulling force onthe locking mechanism comes into action. This depends on the resistanceof the vaginal introitus, and when absent—the device may be removedpainlessly and/or even without collapse.

Exemplary Device Embodiments

FIGS. 1A-1B are perspective views of a collapsed and open, respectively,ball-type prolapse treating device 100 with individual arcs 102connected to two tubes 104 (shown and described in more detail withrespect to FIG. 2 ), 108 and attached to an applicator 130, inaccordance with an exemplary embodiment of the invention. As shown inFIG. 1A and FIG. 1B, the device 100 is configured to transform from acollapsed state 110 to an expanded state 120. In some embodiments of theinvention, the device 100 assumes the collapsed state 110 duringstorage, insertion and/or removal. In some embodiments of the invention,the device 100 assumes the expanded state 120 after insertion and/orduring use to support at least one prolapsed organ from within thevagina.

FIG. 2 is an exploded view of the collapsed ball-type prolapse treatingdevice 100 and the applicator 130 of FIG. 1A, in accordance with anexemplary embodiment of the invention. As shown in the exploded view,the device comprises 3 or more (in this embodiment, 4) bendable arcs 102whose ends are secured by two telescoping tubes 104, 108, where the topend (distal end) 112 of the arcs 102 attach to an outer tube 104 and thebottom end (proximal end) 114 of the arcs 102 attach to an inner tube108. In an embodiment of the invention, telescoping means the inner tube108 slides within the outer tube 104 to adjust the overall length of thedevice 100 and/or the flex or degree of bending of the arcs 102. Itshould be understood that while the tubes 104, 108 are called “tubes”which would imply a cylindrical shape, they are not necessarilycylindrical. For example, outer tube 104 has a square shapedcross-sectional profile in FIG. 2 . In an embodiment of the invention,the outer tube 104 has slots leading snapping pins on the inner tube108. The snapping pins 109, shown in FIGS. 3B-3C, serve as a lockingmechanism by contracting inwards at the end of the slots and moving backto their original position in locking slots in-line with the leadingslots.

In an embodiment of the invention, the arcs 102 are covered by anelastic material layer 116 that serves as padding to reduce pressure onthe vaginal tissue.

In an embodiment of the invention, the applicator 130 is attached to thedevice 100 and used for insertion the device 100 into a vagina and/orfor transforming the device 100 from the collapsed state 110 into theexpanded, ball-like state 120. In an embodiment of the invention, theapplicator 130 includes at least two main components, a pessary holder131 and a puller 132. The holder 131 and puller 132 are configured toallow axial movement of the puller 132 relative to the holder 131, wherethe puller 132 moves axially within the holder 131. Pulling the puller132 in a proximal direction causes the distal end of the device 100 tomove towards the proximal side of the device 100, thereby shortening itsoverall length and causing an outward bowing or expansion of the arcs102.

The puller 132 is removably attached to the outer tube 104 such that thepuller 132 can be selectively released from the outer tube 104 (forexample, after the device 100 has been deployed and the applicator 130is being removed from the vagina, leaving the device in situ).Optionally, the puller 132 and the outer tube 104 are configured ascounterparts with a screwing action that can be detached by rotation,for example where a prong 133 on the distal end of the puller 132rotates within a threaded groove in the outer tube 104 to achieve thiseffect. In some embodiments of the invention, the holder 131 has aninternal rail which leads the prong 133 to the threading only after thepuller 132 has slid within the holder 131 sufficiently to expand thedevice 100 into its expanded state 120. In some embodiments of theinvention, the device is reversibly locked in its ball state (describedin more detail below with respect to FIGS. 3A-3C). In an embodiment ofthe invention, when the applicator 130 is removed a removal string's 120free (proximal) end extends outside the vagina (similar to aconventional menstrual tampon).

FIG. 3A is a perspective view of the prolapse treating device 100 ofFIG. 1B separated/deployed from the applicator 130, in accordance withan exemplary embodiment of the invention. To remove the pessary from thevagina, in an embodiment of the invention, the removal string 120connected to a removal disk 106 is pulled. The removal disk 106 isconfigured to collapse on locking pins 109, pressing the locking pinstowards a central axis of the device 100 and thus releasing the lockingmechanism. Unlocking the locking mechanism allows the device 100 totransform from the ball state 120 back to the collapsed state 110 foreasier removal which is achieved by a sustained proximal on the removalstring 120.

FIGS. 4A-4B are perspective views of a collapsed and open, respectively,ball-type prolapse treating device 400 with 3 or more individual arcs402 integrated with one 407 of two tubes and attached to an applicator430, in accordance with an exemplary embodiment of the invention. Aswith other embodiments described herein, the device 400 is configured toassume a plurality of stable states (e.g. compressed and expanded). Inan embodiment of the invention, the arcs 402 are an integrated componentof an inner tube 407 of the device, shown and described in more detailwith respect to FIG. 5 , where the proximal ends of the arcs 402 areintegrated into the inner tube 407. In some embodiments of theinvention, the distal ends 412 of the arcs 402 are configured to connectto an outer tube 409 within which the inner tube 407 is axially locatedand slidable within, telescopically.

In an embodiment of the invention, an applicator 430 is attached to thedevice 400 and used for insertion of the device 400 into a vagina and/orfor transforming the device from the collapsed state 110 into theexpanded, ball like state 420. The applicator 430 is constructedsimilarly to the applicator 430 of FIG. 1A, including a holder 431 and apuller 432, and functions largely in a similar manner. In an embodimentof the invention, when the applicator 430 is removed a removal string's410 free (proximal) end extends outside the vagina (similar to aconventional menstrual tampon).

As with other embodiments described herein, by pulling the removalstring 410, the removal disk 406 is contracted, bending locking pins 414(shown in more detail in FIGS. 5 and 6 ) inwards towards a central axisof the device and out of counterpart slots on the outer tube 409.Bending the locking pins 414 inwards releases the outer tube 409 fromthe inner tube 407, thus allowing the tubes to slide relative to eachother and returning the device 400 to something akin to the collapsedstate 110 and facilitating easy removal of the device 400 out of thevagina.

FIG. 6 is an exploded view of the ball-type prolapse treating device 400and the applicator 430 of FIG. 4A, in accordance with an exemplaryembodiment of the invention.

FIGS. 7A-7B are perspective closed and open, respectively, views of aball-type prolapse treating device 700 with an outer bar tube 702attached to an applicator 730, in accordance with an exemplaryembodiment of the invention. In an embodiment of the invention, thedevice 700 is configured to transition from a first collapsed state 110to a second, expanded state 120. As with other embodiments describedherein, the first state 110 is used during storage, insertion and/orremoval of the device 700 and the second state 120 is used afterdeployment to render treatment to the user. In an embodiment of theinvention, both states are stable.

In an embodiment of the invention, the applicator 730 is attached to thedevice 700 and used for insertion of the device 700 into a vagina and/orfor transforming the device from the collapsed state 110 into theexpanded, ball like state 120. The applicator 730 includes a holder 731and a puller 732, shown in more detail in FIG. 8 , in an embodiment ofthe invention. In an embodiment of the invention, the holder 731 andpuller 732 are assembled in a way that allows co-axial movement of thepuller 732 within and relative to the holder 731. The puller 732 is heldwithin slots 733 of the upper tube 734, in an embodiment of theinvention. The puller 732 pulls the upper tube 734 in a proximaldirection until the upper tube 734 locks into a lower tube 735, formingthe arcs of the outer bar tube 702 into the expanded ball state 120.Upon expansion of the device 700, the arms of the puller 732 come withcontact with the lower tube 735 and bend inwards. Thus, the puller 732is detached from the slots 733 and is removed together with the holder731, leaving the device inside the user's vagina.

In an embodiment of the invention, when the applicator 730 is removed aremoval string's 710 free (proximal) end extends outside the vagina(similar to a conventional menstrual tampon).

FIG. 8 is an exploded view of the ball-type prolapse treating device 700and the applicator 730 of FIG. 7A, in accordance with an exemplaryembodiment of the invention. In an embodiment of the invention, theouter bar tube 702 is connected on the upper or distal end to the uppertube 734 and the lower or proximal end is connected to the lower tube735. In some embodiments of the invention, a “V” shaped bar 744 holdsthe upper telescopic tube 734 together with the outer bar tube 703.

FIGS. 9A-9B are side views of the ball-type device of FIG. 7B showing aholding bar extended and retracted, respectively, in accordance with anexemplary embodiment of the invention. To remove the device 700 from theuser's vagina, a removal string 740 connected to the bar 744 is pulledin a proximal direction, causing a deflection of the bar 744, releasingthe now-connected telescopic tubes 734, 735 from the outer tube 702 andconverting the device 700 from the expanded, ball state 120 to thecollapsed state 110.

FIGS. 10A-10B are perspective closed 110 and open 120, respectively,views of a ball-type prolapse treating device 1000 with an outer spiraltube 1046 attached to an applicator 1030, in accordance with anexemplary embodiment of the invention.

FIG. 11 is an exploded view of the ball-type prolapse treating device1000 and the applicator 1030 of FIG. 10A, in accordance with anexemplary embodiment of the invention. In an embodiment of theinvention, device 1000 is configured and operates similarly to device700, with the outer bar tube 702 of device 700 replaced by spiral tube1046, shown in FIG. 11 , of device 1000.

FIGS. 12A-12B are side views of the ball-type device of FIG. 10B showinga holding bar 1044 extended and retracted, respectively, in accordancewith an exemplary embodiment of the invention. To remove the device 1000from the user's vagina, a removal string 1040 connected to the bar 1044is pulled in a proximal direction, causing a deflection of the bar 1044,releasing the now-connected telescopic tubes 1034, 1035 from the spiraltube 1046 and converting the device 1000 from the expanded, ball state120 to the collapsed state 110.

FIGS. 13A-13B are perspective closed 110 and open 120, respectively,views of a ball-type prolapse treating device 1300 with opposingu-shaped elements 1302, 1304 attached to an applicator 1330, inaccordance with an exemplary embodiment of the invention.

FIG. 14 is a perspective view of the ball-type prolapse treating device1300 of FIG. 13A split apart into the two component elements 1302, 1304,in accordance with an exemplary embodiment of the invention. In anembodiment of the invention, the two elements 1302, 1304 are assembledconcentrically opposing each other and orthogonal to each other. In anembodiment of the invention, the upper element 1302 is provided with anouter telescoping tube 1306 and the lower element 1304 is provided witha toothed, sliding post 1308. In an embodiment of the invention, thesliding post 1308 slides coaxially within the outer telescoping tube1306 during device 1300 expansion. Teeth 1350 provided to the top ordistal end of the sliding post 1308 are configured to travel within aslot 1352 in the outer telescoping tube 1306, whereby in a reversiblylocked expanded state 120, the elastically deformable, biased teeth 1350are pushed over a block 1354 and snap open, reversibly preventing thedevice 1300 from returning to the collapsed state 110.

In an embodiment of the invention, each of the “U” elements 1302, 1304has an open base. However, by connecting them to each other, each oftheir respective bases are closed by the other element, forming twoorthogonal closed frames (which are deformed into rings in the“expanded” state).

Removal of the device 1300 is achieved by pulling a removal string 1356attached to the teeth 1350 in a proximal direction. The removal string1356 is attached to the teeth 1350 in such a way (for example, by aconnector 1358) as to cause the teeth to move towards a central majoraxis of the device 1300 and out of the slot 1352, allowing the teeth1350 to move past the block 1354, releasing the outer telescoping tube1306 and allowing the device 1300 to return to the collapsed state 110.

The applicator 1330 includes two components: a pessary holder 1331 and apuller 1332. FIG. 15A is a cross-sectional view of the device 1300 ofFIG. 13A, in accordance with an exemplary embodiment of the invention.The puller 1332 is configured with snapping teeth 1335 that snap to theouter telescoping tube 1306, shown in FIG. 15B, a close-up,cross-sectional view of a locking mechanism of the device of FIG. 13A,in accordance with an exemplary embodiment of the invention. In anembodiment of the invention, the snapping teeth 1335 arereinforced/backed by the post 1308 preventing the snapping teeth 1335from bending prematurely. The teeth 1335 are configured such that whenthe device 1300 attains the expanded state 120, the snapping teeth 1335extend past the post 1308, bend inwards and release from the outertelescoping tube 1306. Then, the puller 1332 is removed together withthe holder 1331 and the device 1300 is left inside the user's vagina.

FIG. 16A is a perspective view of a prolapse treating device 1600 in itsclosed state 1610 made of three or more elastic arcs 1602 connected totwo concentric telescopic elements. The device 1600 is attached to anapplicator 1630, in accordance with an exemplary embodiment of theinvention.

FIGS. 16B-16C are perspective views of the prolapse treating device 1600of FIG. 16A in its opened state 1620.

FIG. 17 is an exploded view of the prolapse treating device andapplicator of FIG. 16A showing the assembly relations between thedevice's components, in accordance with an exemplary embodiment of theinvention. The elastic arcs elements 1602 are attached to the lowertelescopic tube 1604 and to the upper telescopic tube 1606 by axisinserted through slots in the telescopic tube elements 1604, 1606. Thelower telescopic tube 1604 has snapping teeth 1608 led by slots withinthe upper telescopic tube 1606. Each of the elastic arcs is covered by apadding cover 1612 to provide better force distribution of the device onvaginal walls.

FIG. 18A is a front view of the device of FIG. 16A in its closed state1610 having a broken out section revealing the elastic arc 1602 and FIG.18B is a front view of the device in its opened state 1620 having asimilar broken out section, in accordance with an exemplary embodimentof the invention. In an embodiment of the invention a plurality ofblocks 1614 are connected to the internal side of each elastic arc 1602.When the telescopic tube elements are pressed towards each other thearcs 1602 are twisted to a smaller radius and the gaps between theblocks 1614 are closed. The telescopic tubes are locked by a lockingmechanism (FIG. 19B) holding the device in the open state and the blocksin contact with each-other. The contact between the blocks elevates therigidity of the device and allows it to keep its shape under theexternal pressure of the vagina.

FIG. 19A is a cross-sectional view of the device 1600 in its openedstate, in accordance with an exemplary embodiment of the invention. Thesnapping teeth 1608 of the lower telescopic tube 1604 slides withinslots in upper telescoping tube 1606 during device 1600 expansion untilthey encounter a “bridge” in the slot, climb and snap to it (FIG. 19B).The snap of the teeth is locking the device 1600 in its open state 1620preventing it from returning to the collapsed state 1610.

Removal of the device 1600 is achieved by pulling a removal string 1616attached to the snapping teeth 1608 in a proximal direction. The removalstring 1616 is threaded in a hole in the snapping teeth 1608. When theremoval string is pulled the snapping teeth move towards a central majoraxis of the device 1600 and released from the “bridge” in the slot ofthe upper telescopic tube 1606, releasing the upper telescoping tube andallowing the device 1600 to return to the collapsed state 1610.

The applicator 1630 includes two components: a pessary holder 1640 and apusher 1650. The holder 1640 is configured with snapping teeth 1642 thatsnap to the rim of the upper telescoping tube 1606, shown in FIG. 16C.The lower telescopic tube 1604 has forward protruding pegs 1618. Whenthe device reaches its expanded state 1620, the pegs 1618 come incontact with the holder snapping teeth 1642, push them over the uppertelescopic tube rim, allowing the snapping teeth to bend outwards andrelease the upper telescopic tube 1606. Then, the holder 1640 is removedtogether with the pusher 1650 and the device 1600 is left inside theuser's vagina.

FIGS. 20A-20B are perspective closed 2010 and open 2020, respectively,views of a prolapse treating device 2000 made of coaxial telescopicelements and a plurality of block elements 2008 attached to anapplicator 2030, in accordance with an exemplary embodiment of theinvention.

FIG. 21 is an exploded view of the prolapse treating device showing theassembly relations between the device's components, in accordance withan exemplary embodiment of the invention. Block elements 2008 areconnected to each other by integral hinges to form a chain 2012. Each ofseveral chains (3 or more) is connected (by hinges) to a lowertelescopic tube 2002 on one of it ends and to an upper telescopic tube2004 on its other end. The lower telescopic tube 2002 has snapping teeth2006 led by slots within the upper telescopic tube 2004.

FIG. 22 is a front view of a chain 2012 made of a plurality of blockelements 2008. When the lower telescopic tube 2002 and the uppertelescopic tube 2004 are pressed towards each other the block elements2008 are rotated around their hinges until they come to full contactwith each-other. When the block elements are in full contact with eachother, the chains have a small radius arc shape and device reaches itsopen state 2020. The telescopic tubes are locked by a locking mechanism(FIG. 23B) holding the ring elements in the open state and the blocks infull contact with each-other. The contact between the blocks elevatesthe rigidity of the device and allows it to keep its shape under theexternal pressure of the vagina.

A padding cover 2060 is placed over the ring elements to provide betterforce distribution of the device on vaginal walls.

FIG. 23A is a cross-sectional view of the device 2000 of FIG. 20A, inaccordance with an exemplary embodiment of the invention. The snappingteeth 2006 of the lower telescopic tube 2002 slide within slots in uppertelescoping tube 2004 during device 2000 expansion until they encountera “bridge” in the slot, climb and snap to it (FIG. 23B). The snap of theteeth is locking the device 2000 in its open state 2020 preventing itfrom returning to the collapsed state 2010.

Removal of the device 2000 is achieved by pulling a removal string 2016attached to the snapping teeth 2006 in a proximal direction. The removalstring 2016 movement deforms the snapping teeth towards a central majoraxis of the device 2000 and out of the slot in the upper telescopic tube2004, releasing the upper telescoping tube and allowing the device 2000to return to the collapsed state 2010.

The applicator 2030 includes two components: a pessary holder 2040 and apusher 2050. The holder 2040 is configured with snapping teeth 2042 thatsnap to the upper telescoping tube 2004. In an embodiment of theinvention, when the device reaches its expanded state 2020, the lowertelescopic tube snapping teeth 2006 push the holder snapping teeth 2042upwards causing them to bend outwards and release from the uppertelescopic tube 2004. Then, the holder 2040 is removed together with thepusher 2050 and the device 2000 is left inside the user's vagina.

FIGS. 24A-24B are perspective views of a prolapse treating device 2400in closed state 2410 and open state 2420, respectively, made of twoorthogonal ring elements 2402 attached to an applicator 2430, inaccordance with an exemplary embodiment of the invention.

FIG. 25 is an exploded view of the prolapse treating device showing theassembly relations between the device's components, in accordance withan exemplary embodiment of the invention. The two ring elements 2402 areplaced orthogonally and coaxially to each other and the lower telescopictube 2404 and upper telescopic tube 2406 are inserted within holes inthe ring elements bases to hold both ring elements. The lower telescopictube 2404 has snapping teeth 2408 led by slots within the uppertelescopic tube 2406. A padding cover 2460 is placed over the ringelements to provide better force distribution of the device on vaginalwalls.

FIGS. 26A-26B are a front views of a ring element 2402, in closed stateand opened state, respectively, in accordance with an exemplaryembodiment of the invention. In an embodiment of the invention, the ringelement 2402 has two opposing arcs 2412. A plurality of blocks 2414 areconnected to the internal side of the arcs. When the two bases of thering elements are pressed towards each other the arcs 2412 are twistedto a smaller radius and the gaps between the blocks 2414 are closed. Thetelescopic tubes are locked by a locking mechanism (FIG. 27B) holdingthe ring elements in the opened state 2420 and the blocks in contactwith each-other. The contact between the blocks elevates the rigidity ofthe device and allows it to keep its shape under the external pressureof the vagina.

FIG. 27A is a cross-sectional view of the device 2400 of FIG. 24A, inaccordance with an exemplary embodiment of the invention. The snappingteeth 2408 of the lower telescopic tube 2404 slides within the uppertelescoping tube 2406 during device 2400 expansion until they encountera locking slot, bend outwards and snap to it (FIG. 27B). The snap of theteeth is locking the device 2400 in its opened state 2420 preventing itfrom returning to the closed state 2410.

Removal of the device 2400 is achieved by pulling a removal string 2416attached to the snapping teeth 2408 in a proximal direction. The removalstring 2416 is attached to a “V” shaped bridge connecting the snappingteeth 2408. When the removal string is pulled the “V” shaped bridge istwisted causing the snapping teeth to move towards a central major axisof the device 2400 and out of the slot in the upper telescopic tube2406, releasing the upper telescoping tube and allowing the device 2400to return to the collapsed state 2410 (FIGS. 28A-28B).

FIG. 29A is a perspective cross-sectional view of device 2400 of FIG.24A, in accordance with an exemplary embodiment of the invention. Theapplicator 2430 includes two components: a holder 2440 and a pusher2450. The holder 2440 is configured with snapping teeth 2442 that snapto the upper telescoping tube 2406, FIG. 29B is a close-up view of alocking mechanism of the device of FIG. 24A and the applicator holdersnapping teeth. In an embodiment of the invention, the holder snappingteeth 2442 are backed by the “V” shaped bridge of the lower telescopictube preventing the holder snapping teeth 2442 from bending prematurely.When the device reaches its expanded state 2420, the lower telescopictube snapping teeth 2408 are released outwards, twisting the “V” shapedbridge in a way that allows the bend inwards and release of the holdersnapping teeth from the upper telescopic tube 2406 (FIG. 29C). Then, theholder 2440 is removed together with the pusher 2450 and the device 2400is left inside the user's vagina.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference.

In addition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

It is the intent of the applicant(s) that all publications, patents andpatent applications referred to in this specification are to beincorporated in their entirety by reference into the specification, asif each individual publication, patent or patent application wasspecifically and individually noted when referenced that it is to beincorporated herein by reference. In addition, citation oridentification of any reference in this application shall not beconstrued as an admission that such reference is available as prior artto the present invention. To the extent that section headings are used,they should not be construed as necessarily limiting. In addition, anypriority document(s) of this application is/are hereby incorporatedherein by reference in its/their entirety.

What is claimed is:
 1. A device sized and shaped for alleviating pelvicorgan prolapse when inserted into a vagina, comprising: a treatmentrendering portion configured to be adjustable between a first, collapsedstate and a second, expanded state, where the second expanded stateextends substantially in three dimensions.
 2. A device according toclaim 1, where the treatment rendering portion comprises a spiral cuttube, with a distal end connected to an upper tube and with a proximalend connected to a lower tube, where the lower tube is coaxial andslidable within the upper tube and where the upper and lower tubes arecoaxial and internal to the outer bar tube.
 3. A device according toclaim 2, where the upper tube and the lower tube releasably interlock toprevent sliding when in the expanded state.
 4. A device according toclaim 3, where the upper tube is configured with a slot within which atleast one locking pin of the lower tube is received to interlock theupper and lower tubes.
 5. A device according to claim 1, where thetreatment rendering portion is shaped like a sphere.
 6. A deviceaccording to claim 1, where the treatment rendering portion is shapedlike a pear.
 7. A device according to claim 1, where the treatmentrendering portion is shaped like an ovoid.
 8. A device according toclaim 1, where the treatment rendering portion is shaped like a cuboid.9. A device according to claim 1, where the treatment rendering portionis rotationally symmetric.
 10. A device according to claim 1, where thetreatment rendering portion does not exhibit uniform flexibility aroundits circumference in the expanded state.
 11. A device according to claim10, where the treatment rendering portion exhibits a plurality of planesof flexibility.
 12. A device according to claim 1, configured to bepermeable to vaginal secretions.
 13. A device according to claim 1,where at least a portion of the treatment rendering portion is providedwith a covering.
 14. A device according to claim 1, further comprising alocking mechanism.
 15. A device according to claim 14, where the lockingmechanism comprises at least one tooth configured to move in a slot,wherein when the slot is provided with a block at least one locking pinis in the window the device is reversibly locked.
 16. A device accordingto claim 14, where the locking mechanism comprises at least one lockingpin configured as a counterpart to a window or slot, wherein when the atleast one locking pin is in the window the device is reversibly locked.17. A device according to claim 1, further comprising a removal devicefor converting the device from the second, expanded state to the first,collapsed state.
 18. A device according to claim 17, where the removaldevice comprises a string.
 19. A device according to claim 18, where theremoval device further comprises a removal disk attached to the string.20. A device according to claim 17, where the removal device furthercomprises a holding bar attached to the string.
 21. A device accordingto claim 1, where the treatment rendering portion comprises three ormore plastic arcs connected to two concentric telescopic elements.
 22. Adevice according to claim 1, where the treatment rendering portioncomprises coaxial telescopic elements and a plurality of block elements.23. A device according to claim 1, where the treatment rendering portioncomprises at least two orthogonal ring elements, forming arcs, with aplurality of blocks connected to an internal side of the arcs.
 24. Asystem for alleviating pelvic organ prolapse when inserted into avagina, comprising: (a) a device according to claim 1; and, (b) anapplicator.
 25. A system according to claim 24, where the applicatorcomprises a holder and a puller.
 26. A system according to claim 25,where a distal end of the puller is configured with a prong forreleasably holding the device to the applicator.
 27. A system accordingto claim 25, where the puller is configured with snapping teeth forreleasably holding the device to the applicator.